BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 13117684 · Received December 30, 2021

    Report

    Report Number
    3003832357-2021-10007
    Event Type
    Death
    Date Received
    December 30, 2021
    Date of Event
    December 8, 2021
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE ENGINEER AND SCHILLER INVESTIGATION TEAM AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT DEVICE FAILED TO PACE. BASED ON THE EVIDENCE AVAILABLE THE REPORTED PROBLEM WAS UNCONFIRMED. FUNCTIONAL ANALYSIS : RECORDED DATA FROM THE FULL DISCLOSURE REPORT (B)(4) SHOWS THAT THE PATIENT WAS TREATED WITH THE EXTERNAL PACEMAKER. THE PACEMAKER WAS STOPPED AND THE ECG RHYTHM STILL SHOWS A VERY LOW HR. THE PACEMAKER IS RESTARTED, AFTER STOPPING AGAIN THE ECG RHYTHM SHOWS ASYSTOLE. THE UNIT WAS THEN SET TO MANUAL DEFIBRILLATION MODE, BUT NO SHOCK WAS DELIVERED. CPR WAS STARTED, CPR WAS STOPPED, AND THE ECG RHYTHM AGAIN SHOWED A DEEP HR. CPR WAS RESUMED. THIS WAS BUT THE PATIENT NEVER CHANGED TO A STABLE ECG RHYTHM AND NO SHOCK WAS DELIVERED. IT MUST BE ASSUMED THAT THE PATIENT WAS DYING AND THEREFORE CPR NO LONGER HAD ANY EFFECT AND NO SHOCKABLE RHYTHM WAS ACHIEVED. WHY THE USER REPORTED A PROBLEM WITH THE ECG RECORDING (ECG CABLES, NOT PADS) CANNOT BE DEDUCED FROM THESE RECORDINGS. HOWEVER, IT COULD WELL BE THAT CONTACT WITH THE ECG ELECTRODES BECAME POOR DURING DYING AND THEREFORE THE ECG RECORDING WAS INTERRUPTED. THE RECORDING OF THE ECG VIA THE PADS WAS ALWAYS GIVEN. BASED ON THE LOG FILES AND THE PDF, AN USER ERROR IS ASSUMED. ECG CABLE HAD FALLEN OFF ACCORDING TO LOG FILES. CAUSE: PADS DISCONNECTED DURING USE OR USER DOES NOT CONNECT PADS CORRECTLY THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES.

    Additional Manufacturer Narrative · 0

    A USER REPORT WAS RECEIVED RELATED TO A REPORTED PATIENT DEATH WHICH IS CURRENTLY BEING INVESTIGATED. AT THE TIME OF REPORTING, THE DEVICE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. FURTHER UPDATES WILL BE PROVIDED WHEN THE DEVICE IS RECEIVED AND INVESTIGATION HAS PROGRESSED.

    Description of Event or Problem · 0

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - REPORTS ON (B)(6) 2021, WHILE ON A CALL WITH THE DEVICE, PATIENT HAD HR 30, GOT A PACER FAILURE, AND PATIENT ARRESTED/EXPIRED. PATIENT WAS (B)(6) MALE THAT WAS UNRESPONSIVE. ECG APPLIED/NOTED HR 30, ATTEMPTED TO PACE THE PATIENT X3 WITHOUT SUCCESS AND PATIENT WENT INTO CARDIAC ARREST/EXPIRED. WHILE ATTEMPTING TO PACE THE PATIENT, IT WOULD WORK FOR SHORT AMOUNT OF TIME AFTER PLUGGING IN THE CABLES, THEN STOP WORKING, PLUG IN AGAIN AND SAME THING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019556 TEMPUS LS - MANUAL LOW ENERGY DEBFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Death